Is Biotest AG FDA approved?

Biotest AG holds 1 FDA-registered establishment in Germany. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Biotest AG's drugs manufactured?

The FDA register lists Dreieich. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.

What drugs does Biotest AG make?

1 product is listed under Biotest AG in the openFDA NDC Directory, most often as solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Biotest AG

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: Germany

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture1Packaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Biotest AG	Landsteiner Str. 5, Dreieich, 63303, Germany (DEU)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize	3001034985315031799

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
YIMMUGO	immune globulin intravenous, human - dira	solution, intravenous	83372-605BLA

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Common questions

Is Biotest AG FDA approved?: Biotest AG holds 1 FDA-registered establishment in Germany. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Biotest AG's drugs manufactured?: The FDA register lists Dreieich. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
What drugs does Biotest AG make?: 1 product is listed under Biotest AG in the openFDA NDC Directory, most often as solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.